Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

Efficacy of Treatment After Distal Radius Fractures Using Dart-throwing Motion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918174
• Other study ID #: SHEBA-15-2085-YY-CTIL
• Status: Completed
• Phase: N/A
• Start date: November 15, 2015
• Est. completion date: March 17, 2019

Study information

• Verified date: April 2019
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rehabilitation following wrist fractures often includes exercising flexion-extension. However, during daily functions, our wrist moves through an oblique plane, named the Dart Throwing Motion (DTM) plane. This plane might be a more stable plane in cases of wrist injuries, since the proximal carpal row remains relatively immobile. However, rehabilitation programs that incorporate exercising in the DTM plane have yet to be explored.

The researchers aimed to evaluate the rehabilitation outcomes following treatment in the DTM plane compared with outcomes following treatment in the sagittal plane after Distal Radius Fracture (DRFs).

Twenty four subjects following internal fixation of DRFs were randomly assigned into a research group . The range of motion, pain levels and functional tests were measured before and after an intervention of 12 treatment sessions. The control group activated the wrist in the sagittal plane while the research group activated the wrist in the DTM plane, via a DTM orthosis.

Description:

Twenty four subjects were recruited after Open Reduction Internal Fixation (ORIF) of DRFs. Inclusion criteria were: individuals aged 18 to 65 years. Individuals with previous orthopedic or neurological impairments of the upper limb or a cognitive impairment were excluded from the study. Subjects were enrolled from the department of hand surgery at the Sheba medical center.

Each subject read and signed an informed consent form pretrial. Each subject went through an intake session documenting personal information, upper limb ROM, pain levels and functional tests recorded by a certified occupational therapist (OT), hand therapist. The Sagittal group activated the wrist mostly in the sagittal plane while the research group activated the wrist also in the DTM plane, via the Modified Dart Splint (MDS).

All of the subjects in both groups received 12 therapy sessions, 30 minutes each one, 2-3 times a week, during 6-8 weeks following the removal of the cast. Certified hand therapists used several different treatment techniques during the sessions, to achieve the primary goals of edema control, increased Range of Motion (ROM), and decreased stiffness. Compressive wrap with retrograde massage, scar management, soft-tissue mobilization, joint mobilization, active motion and ROM exercises were practice patterns used in this study for all subjects, regardless their group. Both groups were instructed to exercise at home, 3 times a day, 10 minutes per exercise session. The MDS was fitted to the subjects in the DTM group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the MDS at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period. The researcher performed weekly phone calls to remind the DTM group to fill these out. The Sagittal group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions.

At the completion of the treatment, the subjects were reexamined by the same evaluator that performed the baseline evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 17, 2019
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years old

• Went through open reduction internal fixation of distal radius fracture.

Exclusion Criteria:

• Individuals with previous orthopedic impairments of the upper limb.

• Individuals with neurological impairments of the upper limb.

• Individuals with a cognitive impairment.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• Dart splint orthosis
The Dart Splint orthosis was fitted to the subjects in the research group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the Dart splint orthosis at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period.

Other:
• Conventional treatment
The control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. Specifically, they were instructed to exercise at home for 10-minute in each session, three times a day (morning, noon and evening), throughout the intervention period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A personal questionnaire	6 questions regarding personal information (age, sex, family status, profession, hand dominance, and injured hand).	baseline
Primary	A house hold work and sport activity questionnaire	10 questions regarding house hold activities (heavy housing and light housing) and sport activities (athletics, spinning, cycling, ball, racket, weights, swimming) were ranked on a Likert scale from 1-4 according to the daily, weekly or monthly amount of time put in to them.	baseline
Primary	Change in the forearm and wrist range of motion	The elbow and wrist active range of motions were measured during pro-supination, flexion-extension, radio-ulnar deviation. Additionally, the DTM plane angle of the wrist was measured according to Bugden's (Bugden, B. (2013). A proposed method of goniometric measurement of the dart-throwers motion. Journal of Hand Therapy, 26(1), 77-80. https://doi.org/10.1016/j.jht.2012.08.003)	Change from baseline forearm and wrist range of motion at two months
Primary	Change in reported pain and function on The Patient-Rated Wrist Evaluation (PRWE) questionnaire.	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in ADL (activities of daily living).; The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0.; Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.	Change from baseline pain and function at two months
Primary	Change in hand function on The Jebsen-Taylor Hand Function Test (JHFT)	The Jebsen-Taylor Hand Function Test (JHFT) was carried out to assess fine motor skills, weighted and non-weighted hand function activities during performance of ADLs and the effectiveness of treatment for hand conditions. Seven subsets of the test represent a broad spectrum of hand function, which includes writing, turning over 3x5 inch cards (to simulate page turning), picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects. To evaluate patient performance, each subset is timed and can be compared to the established norms	Change from baseline hand function at two months
Primary	Grip strength	The Jamar hand dynamometer was used to measure grip strength. Grip strength was measured with the elbow flexed at 90° and the forearm in neutral rotation. A single measure of grip strength was performed during assessment. The second handle position of the dynamometer was used throughout testing.	Following the intervention at two months
Primary	Pinch strength	The B&L engineering pinch gauge pinch meter was used to measure the three pinch strength outcomes: Lateral pinch, Tripod pinch and tip to tip pinch.	Following the intervention at two months
Primary	Satisfaction from the self-training	Satisfaction from the self-training home exercises was rated using a 5-point Likert scale (1- Not satisfied to 5- Extremely satisfied) for 10 statements re self-training home exercises.	Following the intervention at two months
Primary	Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire	The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire, measured the level of satisfaction attributed to assistive technologies, i.e., the DTM orthosis (for the research group only). This questionnaire contained 27 variables which were scored in terms of perceived importance and satisfaction.	Following the intervention at two months